Spectacle lenses of other materials

Spectacle lenses of materials other than glass

CDSCO CLEARANCE · MOHFW CLEARANCE

HSN 9001 50 00 (Spectacle lenses of other materials) is subject to Central Drugs Standard Control Organisation (CDSCO) registration under the Medical Devices Rules, 2017, as spectacle lenses are listed medical devices under G.S.R. 102(E) dated 11-02-2020 issued by the Ministry of Health and Family Welfare (MOHFW). Import is conditional on compliance with all registration and licensing requirements specified in that notification before a bill of entry is filed.

What this is

HSN code

9001 50 00

Chapter

90 · Optical, photographic, measuring, checking, precision, medical or surgical instruments

Primary regulator

CDSCO · Medical Devices Rules, 2017 · G.S.R. 102(E) dated 11-02-2020

Customs documentation

Registration certificate from CDSCO
Import licence from CDSCO
MOHFW notification compliance from MOHFW

Applicable Partner Government Agencies

CDSCOCDSCO·Central Drugs Standard Control Organisation

MOHFWMOHFW·Ministry of Health and Family Welfare

Compliance steps

1
Obtain CDSCO registration for the spectacle lens product under the Medical Devices Rules, 2017 before shipment. The product falls within the notified medical device categories under G.S.R. 102(E) dated 11-02-2020, and import without a valid CDSCO registration renders the consignment liable to detention and confiscation at the port of entry.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017
2
Verify at the bill-of-entry stage that all conditions specified in G.S.R. 102(E) dated 11-02-2020 — including facility registration and importer licensing — are satisfied. Upload the relevant CDSCO registration and import licence documents in e-Sanchit before out-of-charge.
G.S.R. 102(E) dated 11-02-2020, Ministry of Health and Family Welfare · Medical Devices Rules, 2017

A word of counsel

The most common error on this tariff line is treating spectacle lenses as generic optical components rather than notified medical devices. Once a product falls within the G.S.R. 102(E) schedule, all Medical Devices Rules obligations — importer registration, manufacturer registration, and import licence — attach simultaneously; a consignment cleared as an optical instrument without CDSCO documentation faces confiscation and monetary penalty under the Drugs and Cosmetics Act, 1940.

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Frequently asked

Does HSN 9001 50 00 require BIS certification?

No. Spectacle lenses of other materials are not covered by any BIS Quality Control Order. Import is governed by the Central Drugs Standard Control Organisation under the Medical Devices Rules, 2017, pursuant to the Ministry of Health and Family Welfare notification G.S.R. 102(E) dated 11-02-2020.

What CDSCO documents must be uploaded in e-Sanchit for this tariff line?

The CDSCO registration certificate and import licence issued under the Medical Devices Rules, 2017 must be uploaded in e-Sanchit before customs out-of-charge; the specific document codes should be confirmed against the current e-Sanchit document-type schedule at the time of filing.

Does the MOHFW notification G.S.R. 102(E) cover all spectacle lens materials or only specific types?

G.S.R. 102(E) dated 11-02-2020 notifies the category of spectacle lenses as medical devices; importers should confirm whether their specific lens material and form fall within the enumerated product class in that notification before classifying the import as a non-medical optical component.

Last verified against gazette notifications: 2026-05-16. Source: CDSCO / MOHFW / Indian Customs CUSDATA.